Richard Wolf Medical Instruments Corp
Form 483 issued July 17, 2018 · Vernon Hills, Illinois
- Inspection
- Jun 26 – Jul 17, 2018
- Investigators
- Emma R. Schaefer· Jesse A. Vazquez
- Observations
- 6
- Pages
- 8
- FEI number
- 1418479
In short: On July 17, 2018, FDA issued a Form 483 with 6 observations to Richard Wolf Medical Instruments Corp in Vernon Hills, Illinois (FEI 1418479) after an inspection that ran Jun 26 – Jul 17, 2018. The investigators were Emma R. Schaefer and Jesse A. Vazquez. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 0321 CFR 820.20(b)21 CFR 820
The organizational structure has not been adequately established and maintained to ensure that devices are produced…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Emma R. Schaefer
4 documents · 2018–2021
Cites 820.50 (purchasing controls) more than any other section. Most of their documents are for sites in Illinois.
The firmRichard Wolf Medical Instruments Corp history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Richard Wolf Medical Instruments Corp?
FDA listed 6 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The opening words of each observation are shown on this page.
Who inspected Richard Wolf Medical Instruments Corp?
Emma R. Schaefer and Jesse A. Vazquez are named on this Form 483, for the inspection of Jun 26 – Jul 17, 2018. Each investigator has a profile showing what they cite most.
When was Richard Wolf Medical Instruments Corp inspected by FDA?
The inspection ran Jun 26 – Jul 17, 2018, and the Form 483 is dated July 17, 2018.
How do I get the full Form 483 for Richard Wolf Medical Instruments Corp?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.